M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55

Electrode, Electrocardiograph

S & W MEDICO TEKNIK

The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for M55 K Karaya Gum Disp. Microtape Ecg Electrode, 55.

Pre-market Notification Details

Device IDK884983
510k NumberK884983
Device Name:M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
ClassificationElectrode, Electrocardiograph
Applicant S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
ContactLisbeth Isbrandt
CorrespondentLisbeth Isbrandt
S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-29
Decision Date1989-03-09

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